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Trial record 5 of 107 for:    ain457

Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00584740
Recruitment Status : Terminated (The study was terminated prematurely after futility criterion was met at planned interim analysis of 41 patients.)
First Posted : January 2, 2008
Results First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE January 2, 2008
Results First Submitted Date  ICMJE January 28, 2015
Results First Posted Date  ICMJE March 31, 2015
Last Update Posted Date March 31, 2015
Study Start Date  ICMJE August 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score [ Time Frame: 6 weeks ]
The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Mean Crohn's Disease Activity Index (CDAI) [ Time Frame: At 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2015)
  • Percentage of Participants Achieving Remission and/or Response [ Time Frame: 6 weeks ]
    Remission or response was defined as CDAI < 150 points or CDAI reduction from baseline of at least 70 points.
  • Percentage of Participants Achieving Remission [ Time Frame: 6 weeks ]
    Remission was defined as CDAI < 150 points.
  • Percentage of Participants Achieving Response [ Time Frame: 6 weeks ]
    Response was defined as CDAI reduction of at least 70 points from baseline.
  • Mean Change From Baseline in CDAI Score [ Time Frame: baseline, 2 weeks, 4 weeks ]
    The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change in mean score indicates improvement.
  • Area Under CDAI Curve [ Time Frame: 10 weeks ]
    The Crohns Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohns disease. Participants were asked to record on a paper diary the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI score: arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenousum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula; fever; use of antidiarrheal; abdominal mass; hematocrit; body weight. The CDAI score is the sum of the products of each item multiplied by its weighting factor. CDAI ranges from 0 to >=600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. An area under the CDAI response curve analysis was performed with a starting point from week 4.
  • Percentage of Participants Maintaining Remission [ Time Frame: 10 weeks ]
    Remission was defined as CDAI < 150 points.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
- % of subjects achieving remission and/or response (CDAI <150) or a decrease of at least 70 points from baseline - Mean CDAI at 2 and 4 weeks - Maintenance of remission and/or response - Safety/tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single iv Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Active Crohn's Disease
Brief Summary This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: AIN457
    10 mg/kg
  • Drug: Placebo
    Matching placebo to AIN457
Study Arms  ICMJE
  • Experimental: AIN457
    AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
    Intervention: Drug: AIN457
  • Placebo Comparator: Placebo
    Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 6, 2010)
59
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)
72
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female; 18-75 years old
  • Diagnosis of Crohn's disease for at least 3 months prior to screening
  • Confirmation of Crohn's disease by endoscopic or imaging examination
  • Moderately active Crohn's disease at baseline, defined as:
  • CDAI ≥220 and ≤450
  • Active disease despite prior treatment with corticosteroids for at least 2 weeks, or immunosuppressants for at least 3 months. Treatment with azathioprine, 6-MP or MTX is allowed but must have been on a stable dose for at least 10 weeks, corticosteroids are allowed but must have been on a stable doses of prednisolone not exceeding 40 mg for two weeks prior to baseline. Immunosuppressants other than those listed above, such as cyclosporine, tacrolimus and mycophenolate, are not allowed and must be stopped (wash-out periods defined in the protocol);

Exclusion Criteria:

  • Body Mass Index >34
  • Positive PPD tuberculin skin test or QuantiFeron test
  • Any subject with evidence of active pulmonary disease or evidence of latent tuberculosis or fungal infection at screening or within past 3 months
  • Symptoms associated with active bowel structuring disease and pre-stenotic dilation on radiographs
  • Fistulizing disease if complicated by sepsis and/or untreated abscess
  • Multiple bowel surgeries and clinically important short bowel syndrome defined as an inability to maintain caloric intake
  • Use of certain medications as specified in the protocol
  • Clinical improvement due to other Crohn's therapy

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries Canada,   United States
 
Administrative Information
NCT Number  ICMJE NCT00584740
Other Study ID Numbers  ICMJE CAIN457A2202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: NOVARTIS Novartis investigator site
PRS Account Novartis
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP